Breast Cancer
Conditions
Keywords
Early unilateral breast cancer
Brief summary
The initial aesthetic and functional conditions are recorded with the help of the Breast Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer software, allowing for comparison. Determination of the initial quality of life is measured with the European Organisation of Research and Treatment of Cancer - Quality of Life Questionnaire number C30-BR23 (EORTC QoL C30-BR23). Patients then undergo surgical treatment according to institutional protocols. Following conventional marking of the orientation of the specimen, it is measured by an analytical scale. Histological examination of the specimen will record the largest diameters, and parameters of the lymph nodes, according to the institutional protocol. On the 4th week following surgery, assuming that wound healing is completed, patients' data are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance imaging is performed to assess the volume of the contralateral breast. Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each quadrant, threshold value in the quadrants, above of which it is not advisable to perform conventional breast conserving surgery due to poor outcomes.
Interventions
PROCEDURELumpectomy, axillary block dissection, breast conserving surgery
Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node.
OTHERRadiotherapy
Adjuvant radiotherapy carried out by institutional protocols.
Sponsors
National Institute of Oncology, Hungary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 70 Years
Healthy volunteers
No
Inclusion criteria
* early breast cancer * unilateral tumor * tumor size is less than 3 cm
Exclusion criteria
* age over 70 * malignant invasive tumor in the past * pregnancy * previous surgical treatment of the breast or axilla * central breast tumor sizing \<3 cm * a need for mastectomy * tumor size \>3 cm measured by mammography or physical examination * surgical excisions resulting in positive margins * surgical or radiotherapeutic complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results. | 8 months | Data of eligible patients are recorded by the study physicians on a locally developed questionnaire. Digital photos are taken of each patient producing a frontal and two side views. Images are processed by the BCCT.core software (Breast Cancer Conservation Treatment. cosmetic results). Magnetic resonance imaging is implemented and used to calculate breast volume with the help of Amira 5.1 software (Visage Imaging GmbH)trial version. Excised tumor is measured by a validated analytical scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS). | 8 months for each patient | Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. |
| Assessing the relationship between cosmetic+functional results and quality of life. | 8 months for each patient | Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. |
| Assessing the effect of surgical intervention on cosmetic+functional results and quality of life. | During 8 postoperative months | Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. |
| Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life. | During 8 postoperative months | Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. |
| Assessing the clinical applicability of the European Organisation of Research and Treatment of Cancer, Quality of Life Questionnaire C30-BR23 (EORTC QoL C30-BR23) validated questionnaire. | 8 months | Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. |
| Assessing the clinical applicability of the BCCT.core software. | 8 months | Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken. |
Countries
Hungary
Outcome results
None listed